Posted on December 4, 2018 at 10:14 AM
I started writing this on my way back to New York from the Second International Summit on Human Genome Editing, held in Hong Kong November 27 to 29, where the breaking news of the alleged world’s first birth of genetically edited babies loomed large. The surprising news both reinforced and undercut the summit’s goal to “assess the evolving scientific landscape, possible clinical applications, and attendant societal reactions to human genome editing.” In a video introducing the summit, its chairman, the Nobel Prize-winning scientist David Baltimore, said the summit would provide an opportunity “to come together to agree on what we want to do and how we want to do it, and what we consider to be right and wrong on a voluntary basis.”
On the one hand, reports of a rogue scientist, He Jiankui, who contravened the scientific and ethical norms that should guide the development of human genome editing reinforces the need for clarity about those norms and international monitoring of advances in the field. On the other hand, it shows the weaknesses and limitations of voluntary efforts – like the summit – to guide scientists’ practices. They lack any real enforcement power on their own, and have largely served to ensure that human genome editing research can continue, rather than promote reflection on whether we should edit the human germline in the first place.
The 2018 summit came exactly three years after the First Summit on Human Gene Editing, which I also attended in Washington, D.C. in 2015. After the 2015 summit, the organizing committee released a statement saying that it would be “irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application.” The 2018 summit assessed whether these scientific and ethical conditions, respectively, are being met. The organizing committee said no in an updated statement released last week.
What intrigued me most about the summit was the continued emphasis on consensus – or something approaching it – as a condition of moving forward with clinical applications of germline editing. Alongside calls for consensus, summit organizers seemed to embrace the inevitability of germline editing trials. Several scientists shared research that would have clear clinical applications involving editing embryos or gametes. The organizing committee’s 2018 statement says that “it is time to define a rigorous, responsible translational pathway” toward clinical trials of germline editing. And yet, there is not consensus, even among summit panelists (notably those from the humanities), that editing the human germline would ever be responsible.
I was grateful that several panelists and participants problematized the notion of consensus, raising a litany of questions, including: Who are the “we” that need to agree? On what issues is consensus needed? How will we know when we’ve reached consensus? What stories, metaphors, arguments, or moral frameworks are being used to facilitate, if not force, consensus? For my own part, I’m not so sure consensus is a laudable goal, much less an ethically necessary one. I think what these summits have aimed at is more akin to compromise, a provisional agreement among the scientific community to follow certain rules on good faith. Compromise is important: the world needs clarity on whether, when, and how powerful scientists, biohackers, or clinicians are going to proceed with germline genome editing. But this does not require that “we” reach consensus on their moral basis or what ought to come next for the human race.
There’s much scientific work to be done to determine whether human germline genome editing can be made safe, feasible, and accessible. There is a wide range of questions for bioethicists to work out, too. Aside from the very important question of whether we should ever edit the human germline, some questions include:
- Where is the line between research and clinical innovation?
A fascinating panel on research ethics took up the question of whether genome editing is properly within the domain of research or clinical innovation. Juxtaposing the biomedical research establishment and biohacker community, panelists noted that some uses of gene editing explicitly aim to treat patients or help prospective parents, rather than produce generalizable knowledge. It is an open question whether these primarily therapeutic practices count as research or clinical innovation, which matters for how germline genome editing will be regulated going forward. Either way, there was agreement among panelists that carrying out these practices would still require fully informed consent and transparency.
- What sorts of structures, norms, or expectations are barriers to transparency?
If there was widespread agreement on anything, it’s the importance of transparency. In his condemnation of He Jiankui’s actions, David Baltimore lamented the “failure of self-regulation by the scientific community because of a lack of transparency.” We need more understanding about barriers to transparency, and efforts to lower them, in order to foster a culture among especially young scientists that rewards raising questions, whistleblowing, and sharing works in progress.
Coupled with transparency about the science itself, going forward nonscientists and especially journalists have a role to play in monitoring financial conflicts of interest. Nearly every scientist who presented at the Summit disclosed a financial conflict of interest.
- What is the relationship between governance and public engagement?
The last two panels of the summit were on governance and public engagement, respectively. Speakers on the panel titled “Identifying Basic Principles for Moving Forward” called for robust governance, including national regulations, international treaties, and a global observatory for gene editing. Then, during the panel “Public Engagement Efforts,” speakers shared examples of local events at museums and high schools, and with patient groups that aimed to foster critical thinking and discussion about the use of medical and reproductive technologies, like stem cell therapies and gene editing. These two panels called for very different types of activities going forward. Their calls are not mutually exclusive, though my sense was that some members of the scientific organizing committee were more enthusiastic about public engagement than about governance. What kind of public engagement process should precede the creation of governance structures and the role of public engagement efforts in governing genome editing technologies remains up for debate.
Within these two paths forward, we encounter a series of questions:
- What kind of governance structures should be put in place?
The task ahead includes creating oversight structures at a variety of levels: institutional, local, national, international, professional organizations, etc. Creating this infrastructure and coordinating across these levels will be challenging, and probably frustratingly slow for some scientists. The 2018 summit statement specifically calls for continued meetings to “speed the development of regulatory science.” One argument that I heard during the summit laments that governance slows down innovation, and any delay in delivering germline gene therapies means that more people are born with debilitating diseases than would otherwise. It’s important to keep articulating responses to this common refrain. Governance protects people, and democratic governance, while slower than an authoritarian or technocratic regime, institutionalizes a commitment to equal power among people to shape our world, including future generations of humans.
- What kinds of public engagement efforts will facilitate meaningful education, dialogue, and deliberation about human genome editing?
I was impressed with the examples of public engagement activities that were shared by panelists on the final panel because they seemed to have fostered critical thinking and achieved dialogue about the topic at hand. Examples included a workshop for high school students to learn about gene editing. The events described were not meant to provide international guidance or achieve consensus on an issue, but rather to raise awareness and create informed publics. When public engagement is put toward the end of achieving “widespread consensus about” or “widespread acceptance of” the inevitability of germline editing it is no longer engagement but advertising. Those leading engagement efforts, creating curricula for high school students, or hosting public events might even stoke dissent in order to facilitate inclusive and expansive conversations not only about genome editing, but also about the kind of worlds we want to live in.
- How much risk to future persons will we tolerate? Assuming scientists agree upon best scientific practices, for example, for identifying negative consequences of genome editing in embryos, what level of risk will research ethics allow parents to assume on behalf of their future children?
The risks to future children from editing embryos, sperm, or eggs will never be zero. Risks are always relative, however. How should we weigh lowering the risk of sickle cell anemia with possibly increasing the risk of cancer, which can result from off-target genetic mutations? More importantly, who should have the authority to decide these questions? Our research ethics paradigm in the United States typically leaves these decisions up to parents, who will be asked to provide informed consent to the use of gene editing in their children, whether in a research or clinical context. Should that paradigm rule the day, or should we welcome some level of paternalism? We might, for example, require consent from a neutral third party who explicitly represents the interests of future children.
As I left Hong Kong, my thoughts were with the twins said to have come from gene-edited embryos. I hope they are happy, safe, and, for their parents’ sake, eating and sleeping well. We would do well to remember that the people most affected by germline genome editing are these babies. How will their health be affected? Their reproductive potential? If they choose to have children, will they face extra hurdles? Will their lives be dominated by hospital visits, check-ups, and media frenzy? Will they be viewed differently by their parents, friends, or society? How will that affect their family life, friendships, jobs, and relationships? Most of the defenses of germline gene editing that I heard in Hong Kong have to do with parents’ strong desire to have a genetically related child with or without particular traits. That’s an important and in many cases a laudable goal. So is making sure that any child brought into the world has the love, support, freedom, environment, and educational opportunities to flourish, whatever their genotype.
Carolyn P. Neuhaus is a research scholar at The Hastings Center. She thanks the Chinese University of Hong Kong Centre for Bioethics for hosting her visit to Hong Kong.
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